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Asthma inhaler showdown: generic vs. Brand-Name – study pulled before start

NCT ID NCT07223294

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see if a generic version of the fluticasone furoate/vilanterol inhaler (Sandoz) works as well as the brand-name Breo Ellipta in adults with asthma. Participants would have stopped their usual asthma meds and used only the study inhaler or a placebo for 4 weeks. However, the study was withdrawn before any volunteers were enrolled, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Expected to start

Apr 2026

An estimate. Start dates often move.

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Capable of giving signed informed consent (as described in the protocol), which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol. * Participants must be 18 to 75 years old (inclusive) at Screening (signing the ICF). * Diagnosis of asthma, as defined by the National Asthma Education and Prevention Program, at least 12 weeks prior to Screening. * Participants who are stable on their chronic asthma treatment regimen for at least 4 weeks prior to Screening. * Pre-bronchodilator FEV1 of \>40% and \<85% of predicted value, at Screening. * Participants with FEV1 reversibility of ≥12% and ≥200 mL within 30 minutes following 360 mcg of albuterol inhalation (via pressurized metered dose inhaler pressurized metered-dose inhaler \[pMDI\]) or equivalent at Screening. * This what you mean: Participants who are currently non-smoking and have not used tobacco smoking or smoked marijuana products, within the past year. * Participants who are able to replace their current regularly scheduled short-acting β2-agonists (SABAs) with a salbutamol/albuterol inhaler for use only on an 'as-needed' basis for the duration of the study. * Participants must be able to discontinue their asthma medications during the Run-in period, and for the remainder of the study. * Participants who can demonstrate the correct use of inhaler device (during the Run-in period and at Randomization visit). * Participants are eligible to participate in this study if they are: * Of non-childbearing potential * Of childbearing potential, and if they agree to use a highly effective form of contraception consistently during the study, starting at Screening and until the end of study (EOS). These participants must have a negative pregnancy test at Screening and Randomization visit. * Participants who produce viable sperm and have a partner of childbearing potential, and if they agree to use an adequate method of contraception consistently during the study, starting at Screening and until the EOS and also refrain from donating sperm during this period. Participants with a partner or partners who is (are) not of childbearing potential are exempt from these requirements. Exclusion Criteria: * Participants who have life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma-related syncopal episodes(s), or hospitalizations within one year prior to Screening or during the Run-in period. * Participants with significant chronic respiratory disease (COPD, interstitial lung disease, etc) other than asthma which in the opinion of the Investigator may interfere with the study evaluation or optimal participation in the study. * Participants with evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, cardiac dysrhythmia, significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that in the opinion of the Investigator, would put them at risk through study participation, or would affect the study analyses if the disease exacerbated during the study. * Participants with asthma exacerbations (ie, acute or sub-acute worsening in symptoms and lung function from the participant's usual status) within 6 weeks prior to Screening or during the Run-in period. * Participants with evidence or history of tuberculosis (additionally confirmed with a chest X-ray done within 6 months prior to Screening for countries with high tuberculosis risk). * Participants with uncontrolled allergic rhinitis within 15 days prior to Screening. * Viral, bacterial, fungal, or parasitic, acute upper or lower respiratory tract infection (including Coronavirus Disease (COVID-19)), or sinus, or middle ear infection within 4 weeks prior to Screening, during the Run-in period, or at the Randomization visit. Note: Rescreening of participants with acute respiratory conditions during the Screening and Run-in period may be allowed in consultation with Medical Monitor (Section 5.4). * Participants with a history of hepatitis B, hepatitis C, or human immunodeficiency virus 1 and 2. * Participants with clinically significant screening laboratory and electrocardiogram (ECG) parameters as per Investigator's assessment. * Participants receiving systemic, oral, parenteral or depot corticosteroids, or anti-immunoglobulin E (IgE) therapy within 12 weeks prior to Screening spirometry or unable to stop receiving these medications during the study. * Participants receiving β2-blockers, anti-arrhythmics, anti-depressants, monoamine oxidase inhibitors, cytochrome P450 3 subfamily A member 4 (3A4) inhibitors, or diuretics within 4 weeks prior to the Screening spirometry or unable to stop receiving these medications during the study. * Participants receiving monoclonal antibodies that may affect the course of asthma within 180 days prior to the Screening spirometry or unable to stop receiving these medications during the study. * Participants receiving live attenuated vaccines within two days prior to Screening. * Participants who received an investigational drug within 28 days or 5 half-lives (whichever is longer) prior to Screening. * Hypersensitivity to any sympathomimetic drug (eg, albuterol, vilanterol) or to any inhaled, intranasal, or systemic corticosteroid therapy, or to milk proteins, or to excipients in the dry powder inhaler. * Participants with significant alcohol or controlled substance abuse in the past 6 months, per the judgment of the Investigator. * Participants with any factors (eg, infirmity, disability, or geographic location) that the Investigator feel would likely limit the participants' compliance with the study protocol or scheduled clinic visits. * Participants who cannot communicate reliably or who are unlikely to co-operate with the requirements of the study, in the opinion of the Investigator. Participants who are pregnant, breastfeeding, or planning to become pregnant during the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Sandoz Investigational Site

    Cullman, Alabama, 35055, United States

  • Sandoz Investigational Site

    Bradenton, Florida, 34208, United States

  • Sandoz Investigational Site

    Leesburg, Florida, 34748, United States

  • Sandoz Investigational Site

    Orlando, Florida, 32789, United States

  • Sandoz Investigational Site

    St Louis, Missouri, 63141, United States

  • Sandoz Investigational Site

    Raleigh, North Carolina, 27607, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.